Entyvio effective in pediatric IBD, ‘should be included in our treatment paradigm’

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Key takeaways:

  • At 1 year, 40% of children with UC and 23% with CD were in sustained steroid-free remission with vedolizumab.
  • Those with no response by week 6 “had a low likelihood of achieving remission thereafter.”

WASHINGTON — Entyvio is “safe and effective” for maintaining sustained steroid-free remission at 1 year in children with inflammatory bowel disease, more so in those with ulcerative colitis vs. Crohn’s disease, according to a researcher.

“We know that children with inflammatory bowel disease, compared to adults, can have a more severe disease phenotype that is refractory to conventional therapies,” Ronen E. Stein, MD, a gastroenterologist at Children’s Hospital of Philadelphia and assistant professor of clinical pediatrics at University of Pennsylvania Perelman School of Medicine, told Healio. “Unfortunately, there are limited treatment choices for children as only two medicines are FDA-approved for pediatric IBD — infliximab and adalimumab. Therefore, novel therapies are needed to fill this treatment gap in pediatric IBD.”

Stein continued: “Vedolizumab is approved for adults with IBD, but until the VEDOKIDS study, its long-term use had not been studied in a large, multicenter prospective cohort of children with IBD.”

To assess the efficacy and safety of Entyvio (vedolizumab, Takeda Pharmaceuticals) in a pediatric population, Stein and colleagues prospectively followed 137 children (mean age, 14.9 years) with IBD through 1 year at 17 international centers. Sixty-four patients had CD and 73 had UC.

The primary outcomes were sustained steroid-free remission (SSFR) and exclusive enteral nutrition-free remission at weeks 30 and 54 in intention-to-treat analyses.

“At 1 year, 40% of the children with ulcerative colitis and 23% of the children with Crohn’s disease were in sustained steroid-free remission,” Stein said.

However, according to results presented at Digestive Disease Week, 13% of patients with CD and 22% with UC did not achieve response or remission with vedolizumab at week 6, a trend that persisted to week 14 (7% and 24%, respectively).

“Children not achieving a response by week 6 — especially those with Crohn’s disease — had a low likelihood of achieving remission thereafter,” Stein said, noting “a change of medicine should be considered” in patients with CD who do not respond after 6 weeks of therapy.

Disease activity scores, including the weighted Pediatric Crohn’s Disease Activity Index and Pediatric Ulcerative Colitis Activity Index, were the best the predictors of SSFR, researchers reported.

There were 197 adverse events reported among 78 children, of which 11 were likely related to vedolizumab. Two children discontinued treatment due to adverse events.

“Our results show that vedolizumab is a safe and effective therapy that should be included in our treatment paradigm for pediatric IBD,” Stein told Healio. “This cohort of 137 children will continue to be followed beyond 54 weeks to assess longer-term safety and efficacy.”

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